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HSA GN-35

GN-35

Guidance on Special Access Routes (SAR) for Medical Devices
SingaporeHealth Sciences AuthorityRegistration
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What this code is

GN-35 is the official HSA identifier for “Guidance on Special Access Routes (SAR) for Medical Devices”. GN-35 is the official identifier HSA uses for this instrument.

Instrument
GN-35
Full name
GN-35
Category
Registration
Source links
Authority source
English
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11 articles · 1 language version
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Dates
Published
September 2025
Effective
—
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English full text11 articles · English — official textRead HTML →
About this regulation

Guidance on Special Access Routes (SAR) for Medical Devices

HSA GN-35 Revision 5 (September 2025) on the Special Access Routes: supplying unregistered devices for special clinical needs, declaration on distribution records, and the associated forms. Exact PDF from the official guidance-documents collection. Appendices 3, 4, 4.1, and 5 are form pages whose templates are embedded images, so only their titles extract; the substantive requirements live in sec 1 through sec 5.

GN-35 is the official identifier HSA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

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